Labeling Pilot for FDF Country of Origin, API Country of Origin, and KSM Country of Origin for Pharmaceutical Products

1. Purpose The Defense Logistics Agency (DLA) Troop Support Medical Supply Chain is conducting market research to identify U.S. or international pharmaceutical manufacturers that are willing to participate in a labeling pilot program. The pilot seeks to explore voluntary inclusion of additional product labeling data for Pharmaceutical Products identifying: Country of origin for the Finished Dose Form (FDF) Country of origin for each Active Pharmaceutical Ingredient (API) Country of origin for each Key starting material (KSM) necessary for the production of each API Given the amount of information requested, inclusion of a QR code or link to additional information, or other methods of making the information accessible, could be considered If the country of origin of the API or KSM can vary by lot produced, DLA would be interested in the information specific to the labeled lot and to any previously produced lots This RFI is issued solely for information and planning purposes. It does not constitute a solicitation, and responses do not commit the Government to any future acquisition or requirement. 2. Background DLA Troop Support Medical is evaluating methods to improve supply chain transparency, enhance traceability, and strengthen operational readiness by increasing visibility into the sourcing of pharmaceutical ingredients. Understanding FDF, API, and KSM origins helps support contingency planning, risk modeling, and alignment with emerging regulatory and strategic sourcing initiatives. The agency is exploring the feasibility of obtaining this information directly from manufacturers through voluntary labeling enhancements on packaging, shipping containers, or supplemental documentation. 3. Scope of Pilot The proposed labeling pilot will focus on a selected subset of generic pharmaceutical products purchased by DLA Troop Support Medical. Participating manufacturers may be asked to provide: API country of manufacture API country of origin (if different) Country of origin for the Finished Dose Form (FDF) Country of origin for each Key starting material (KSM) necessary for the production of each API If the country of origin of the API or KSM can vary by lot produced, DLA would be interested in the information specific to the labeled lot and to any previously produced lots Placement of this information on external packaging, product containers, or accompanying supply chain documentation Given the amount of information requested, inclusion of a QR code or link to additional information, or other methods of making the information accessible, could be considered Estimated production or administrative impact associated with adding these data elements DLA seeks to understand both operational feasibility and industry readiness. 4. Requested Information from Respondents Interested manufacturers are invited to submit a written response addressing the following: A. Company name, CAGE code, point of contact information B. Description of the pharmaceutical products you manufacture that are supplied or could be supplied to DLA C. Willingness to participate in a voluntary labeling or data?sharing pilot to include: Development of a labeling construct that contains all relevant sourcing information as outlined below. Obtaining approval of the labeling construct from the Food and Drug Administration. Producing labels with all required sourcing information and affixing them to products sold to the Department of War. D. Ability to provide the following information for each lot produced: API country of manufacture API country of origin (if different) Country of origin for the Finished Dose Form (FDF) Country of origin for each Key starting material (KSM) necessary for the production of each API If the country of origin of the API or KSM can vary by lot produced, DLA would be interested in the information specific to the labeled lot and to any previously produced lots Placement of this information on external packaging, product containers, or accompanying supply chain documentation Given the amount of information requested, inclusion of a QR code or link to additional information, or other methods of making the information accessible, could be considered Estimated production or administrative impact associated with adding these data elements E. Existing internal capabilities or systems that support API and KSM traceability and documentation F. Expected timeline and level of effort required to implement labeling modifications G. Any concerns, limitations, or cost impacts associated with participation H. Recommendations for structuring or scaling the pilot program 5. Submission Instructions Responses should be submitted via email in PDF or Word format to the DLA Troop Support Medical Supply Chain point of contact: Contracting Officer: Charles T. Reimer DLA Troop Support – Medical Supply Chain Email: [email protected] Phone: 267-251-9370 (Cell)